UnitedHealth Group 2012 earnings up 8% to $5.5 bln
Leading healthcare company UnitedHealth Group reported 2012 earnings of more than $5.5 billion on $110.6 billion in revenue, an 8% increase in the earnings and 9% increase in the gross revenue from 2011.
The net earnings for the company’s fourth quarter, which ended Dec 31, were $1.2 billion or $1.20 per share, which was in line with Wall St. analyst estimates.
The executives of the company pointed to an increase in premiums as the primary drivers of the 2012 results, with the added benefit that medical costs did not rise as rapidly last year as UnitedHealth had forecast.
The analysts also said, “Overall a solid quarter with few surprises, but less impressive than the company’s performance earlier in the year.” They also said, “On the positive side, the healthcare company noted medical cost trend came in below 5.5% compared to its 3Q commentary that trend was running at 5.5%.”
The company did not see the fourth quarter medical costs increase in the fourth quarter by 12% to $20.8 billion. Executives were of the view that the performance of the company’s health services business Optum and its three divisions that rose by 65% was particularly strong.
The company also significantly increased its membership to 40.9 million, with 4 million new members alone coming from its acquisition earlier in the year of Brazil’s largest insurance company Amil Participacoes S.A. for $3.5 billion.
The healthcare company’s estimates for 2013 revenues remained at $123 billion to $124 billion and net earnings in the range of $5.25 to $5.0 per share per prior guidance.
The market’s reaction to the company earnings was tepid, with UnitedHealth shares trading up 28 cents to $53.94, an increase of about .5 percent or roughly in line with the daily movement of the broader markets.
UnitedHealth Group is a diversified healthcare company based in Minnesota, USA. It offers spectrum of products and services through two operating businesses United Healthcare and Optum. The company is the parent of UnitedHealthcare, the largest single health carrier in the U.S.
A guide to labelling compliance for medical devices
Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.
Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.
But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it.
On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.
Putting a plan in place
MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.
Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance. They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.
When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.
Why labelling in the cloud offers a roadmap forward
Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.
The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.
When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.
A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.
The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.
While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.
Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.